Cleared Traditional

VitalDetect (K231625) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231625 · Wellvii, Inc. · Cardiovascular device
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Feb 2024
Decision
245d
Days
Class 2
Risk

K231625 is an FDA 510(k) clearance for the VitalDetect. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Wellvii, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on February 2, 2024 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Wellvii, Inc. devices

Submission Details

510(k) Number K231625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date February 02, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K231625.
Digital Thermometer
K230889 · Wenzhou Yosun Medical Technology Co.,Ltd · Apr 2024
Probe Covers (YF-001, YF-002)
K240023 · Shenzhen YI Fang Blister Packaging Co., Ltd. · Mar 2024
Infrared Thermometer: Model YJ600
K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · Feb 2024
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
K232338 · Alicn Medical (Shenzhen), Inc. · Dec 2023
THERMOCLICK
K222057 · T&R BIOFAB CO., Ltd. · Dec 2023